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Tepmetko Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Tepmetko Indications
Indications
In adults with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
Tepmetko Dosage and Administration
Adult
Confirm presence of MET exon 14 skipping alterations in plasma or tumor specimens. Swallow whole. Take with food. 450mg once daily until disease progression or unacceptable toxicity. If difficulty swallowing solids: disperse tab(s) in 30mL non-carbonated water; stir and drink immediately or within 1hr; followed with additional 30mL rinse and drink immediately. Also, may give via NG-tube. Dose modifications for adverse reactions: see full labeling.
Children
Tepmetko Contraindications
Not Applicable
Tepmetko Boxed Warnings
Not Applicable
Tepmetko Warnings/Precautions
Warnings/Precautions
Monitor for pulmonary symptoms indicative of ILD/pneumonitis; withhold immediately if suspected and permanently discontinue if no other causes are identified. Monitor LFTs prior to initiation, every 2 weeks during 1st 3 months, then once monthly or as clinically indicated; test more frequently if increased AST, ALT or bilirubin develops. Monitor amylase, lipase at baseline and regularly during treatment. Severe renal (CrCl <30mL/min) or hepatic (Child-Pugh C) impairment. Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 1 week after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).
Tepmetko Pharmacokinetics
Absorption
Median Tmax of tepotinib: 8 hours (range from 6–12 hours).
Geometric mean (CV%) absolute bioavailability (in the fed state): 71.6% (10.8%) in healthy subjects.
The mean AUC0-INF of tepotinib increased by 1.6-fold and Cmax increased by 2-fold, following administration of a high-fat, high-calorie meal.
Distribution
Apparent volume of distribution (VZ/F): 1,038 L (24.3%).
Plasma protein bound: 98%.
Elimination
Fecal (~85%), renal (13.6%).
Half-life: 32 hours.
Apparent clearance (CL/F): 23.8 L/h (87.5%).
Tepmetko Interactions
Interactions
Tepmetko Adverse Reactions
Adverse Reactions
Edema, fatigue, nausea, diarrhea, musculoskeletal pain, dyspnea; Grade 3 or 4 lab abnormalities (decreased lymphocytes, decreased albumin, decreased sodium, increased GGT, increased amylase, increased ALT/AST, decreased hemoglobin); hepatotoxicity, pancreatic toxicity.
Tepmetko Clinical Trials
See Literature
Tepmetko Note
Not Applicable
Tepmetko Patient Counseling
See Literature
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